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Cardio-Pulmonary Exercise Testing in Healthy Population

Primary Purpose

Healthy Obesity, Metabolically

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
exercise test
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Obesity, Metabolically focused on measuring exercise, maximal exercise test, exercise protocol, metabolic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy 18-55

Exclusion Criteria:

  • Physical activity limitation due to orthopedic , neurological and cognition deficit Pregnancy children

Sites / Locations

  • The BARUCH PADEH Medical Center, PoriyaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Healthy

Arm Description

Healthy participants will do both cycle ergometer and treadmill exercise

Outcomes

Primary Outcome Measures

VO2 MAX
maximal oxygen consumption
RPE-rate of perceived exertion
rate of perceived exertion on a 10 point modified Borg scale
Max heart rate
Max heart rate

Secondary Outcome Measures

Full Information

First Posted
December 19, 2021
Last Updated
February 6, 2022
Sponsor
The Baruch Padeh Medical Center, Poriya
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1. Study Identification

Unique Protocol Identification Number
NCT05242211
Brief Title
Cardio-Pulmonary Exercise Testing in Healthy Population
Official Title
Protocols Adjustments for Cardio-Pulmonary Exercise Testing in Healthy Population
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Baruch Padeh Medical Center, Poriya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Introduction: Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. The test progression include an incremental stepwise or ramp control protocol to exhaustion There are different methods used in various clinical setting. CPET involves the measurement of respiratory gas exchange i.e. oxygen uptake, carbon dioxide, minute ventilation, other variables while monitoring ECG, blood pressure, pulse oximetry and exertion perceived (Borg Scale) during an incremental test on a cycle-ergo meter or treadmill. This test allow to assess an integrative exercise responses to submaximal and maximal effort. Aim: To compere exercise responses and achieved criteria for maximal exercise testing with different exercise protocol Methods: Healthy volunteers (normal and overweight ) will be recruited to participants in the study. Demographics (age, sex), anthropometric (height, weight, abdominal circumference), will be measured. By using questionnaire, physical activity behavior and motivation toward engage in physical activity will be filled by the participants. Each participants will conducted an exercise test on treadmill (using Modified Bruce Protocol) and cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange. 10 minute after the graded exercise test Supra maximal exercise test (SMT) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test. All exercise parameter done on the different ergometer will be compared

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Obesity, Metabolically
Keywords
exercise, maximal exercise test, exercise protocol, metabolic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Healthy volunteers (normal and overweight ) will be recruited to participants in the study. Demographics (age, sex), anthropometric (height, weight, abdominal circumference), will be measured. By using questionnaire, physical activity behavior and motivation toward engage in physical activity will be filled by the participants. Each participants will conducted an exercise test on treadmill (using Modified Bruce Protocol) and cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange. 10 minute after the graded exercise test Supra maximal exercise test (SMT) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Other
Arm Description
Healthy participants will do both cycle ergometer and treadmill exercise
Intervention Type
Other
Intervention Name(s)
exercise test
Intervention Description
Each participants will conducted an exercise test on treadmill (using Modified Bruce Protocol) and cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange. 10 minute after the graded exercise test Supra maximal exercise test (SMT) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test.
Primary Outcome Measure Information:
Title
VO2 MAX
Description
maximal oxygen consumption
Time Frame
through study completion, an average of 1 year
Title
RPE-rate of perceived exertion
Description
rate of perceived exertion on a 10 point modified Borg scale
Time Frame
through study completion, an average of 1 year
Title
Max heart rate
Description
Max heart rate
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy 18-55 Exclusion Criteria: Physical activity limitation due to orthopedic , neurological and cognition deficit Pregnancy children
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gur Mainzer, MD
Phone
+972543078940
Email
GMainzer@poria.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Einat Kodesh, PhD
Phone
+972523489854
Email
Ekodesh@poria.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gur Mainzer, MD
Organizational Affiliation
The Baruch Padeh Medical Center, Poriya
Official's Role
Principal Investigator
Facility Information:
Facility Name
The BARUCH PADEH Medical Center, Poriya
City
Teverya
State/Province
The Lower Galilee
ZIP/Postal Code
15208
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19199208
Citation
Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.
Results Reference
background
PubMed Identifier
27875494
Citation
Bhammar DM, Stickford JL, Bernhardt V, Babb TG. Verification of Maximal Oxygen Uptake in Obese and Nonobese Children. Med Sci Sports Exerc. 2017 Apr;49(4):702-710. doi: 10.1249/MSS.0000000000001170.
Results Reference
background
PubMed Identifier
9857276
Citation
Kaminsky LA, Whaley MH. Evaluation of a new standardized ramp protocol: the BSU/Bruce Ramp protocol. J Cardiopulm Rehabil. 1998 Nov-Dec;18(6):438-44. doi: 10.1097/00008483-199811000-00006.
Results Reference
background
PubMed Identifier
17218891
Citation
Hawkins MN, Raven PB, Snell PG, Stray-Gundersen J, Levine BD. Maximal oxygen uptake as a parametric measure of cardiorespiratory capacity. Med Sci Sports Exerc. 2007 Jan;39(1):103-7. doi: 10.1249/01.mss.0000241641.75101.64. Erratum In: Med Sci Sports Exerc. 2007 Mar;39(3):574.
Results Reference
background
PubMed Identifier
19370041
Citation
Midgley AW, Carroll S, Marchant D, McNaughton LR, Siegler J. Evaluation of true maximal oxygen uptake based on a novel set of standardized criteria. Appl Physiol Nutr Metab. 2009 Apr;34(2):115-23. doi: 10.1139/H08-146.
Results Reference
background
PubMed Identifier
29218470
Citation
Schaun GZ. The Maximal Oxygen Uptake Verification Phase: a Light at the End of the Tunnel? Sports Med Open. 2017 Dec 8;3(1):44. doi: 10.1186/s40798-017-0112-1.
Results Reference
background
PubMed Identifier
19706003
Citation
Lafortuna CL, Lazzer S, Agosti F, Busti C, Galli R, Mazzilli G, Sartorio A. Metabolic responses to submaximal treadmill walking and cycle ergometer pedalling in obese adolescents. Scand J Med Sci Sports. 2010 Aug;20(4):630-7. doi: 10.1111/j.1600-0838.2009.00975.x. Epub 2009 Aug 23.
Results Reference
background
PubMed Identifier
28510504
Citation
Mezzani A. Cardiopulmonary Exercise Testing: Basics of Methodology and Measurements. Ann Am Thorac Soc. 2017 Jul;14(Supplement_1):S3-S11. doi: 10.1513/AnnalsATS.201612-997FR.
Results Reference
background
PubMed Identifier
29968559
Citation
Lollgen H, Leyk D. Exercise Testing in Sports Medicine. Dtsch Arztebl Int. 2018 Jun 15;115(24):409-416. doi: 10.3238/arztebl.2018.0409.
Results Reference
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Cardio-Pulmonary Exercise Testing in Healthy Population

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